Bone Remodeling DisorderNCT05375331
Clinical and Genetic Markers of Bone Metabolism in Children Under One Year
An observational study of Bone Remodeling Disorder and Child Development, run by West Kazakhstan Medical University at 1 site in Kazakhstan.
Trial summary
The study of children under one year of age for molecular genetic testing-VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) with the study of the frequency distribution of alleles and genotypes by polymorphisms, analysis of the relationship of molecular genetic markers with indicators of bone metabolism. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Bone Remodeling Disorder, Child Development, Genetic Change
- How many people
- 245 participants
- Where
- 1 siteKazakhstan
- Study dates
- 31 Dec 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- Child
Study population: In accordance with the goal and objectives of the project, 245 children under the age of one year from the Kazakh population born in Aktobe will be examined. (N*-13500, p=16% n=204 +20%(41)=245 children). *N is the total fertility of children; n is how many children should be taken + 20% losses. total for research you need 245
Who may be able to join
- -Children 0 -12 months old
Who cannot join
- Musculoskeletal system diseases;
- Severe chronic somatic diseases;
- Supplementation of vitamin D in a therapeutic dose;
- Lack of consent of the parents or legal representatives to participate in the study.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Irina Kim
Aktobe, 040017
Irina Kim, +77015281354, irina.kim.90@mail.ru
About this study
Official title: Clinical and Genetic Markers of Bone Metabolism in Children Under One Year of Age in the Kazakh Population
The study of children under one year of age for molecular genetic testing-VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) with the study of the frequency distribution of alleles and genotypes by polymorphisms, analysis of the relationship of molecular genetic markers with indicators of bone metabolism.
Read the detailed description
Children under the age of one year of Kazakh nationality born in Aktobe will be examined.
Each child included in the study will have an individual registration card, where information about the health status of the child and the health status of the mother during pregnancy will be filled in.
A biochemical analysis will be determined for the level of calcium, phosphorus, calcitonin, parathyroid hormone, osteocalcin, vitamin D in blood serum and deoxypyridinoline in urine.
Blood will be taken to determine the genetic polymorphism of VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759).
The state of bone tissue remodeling (osteocalcin, vitamin D, Ca, P, calcitonin, deoxypyridinoline) will be revealed The frequencies of allelic variants of the VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) genes in children under the age of one year in the population of Kazakhstan were determined.
- Conditions
- Bone Remodeling Disorder, Child Development, Genetic Change
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization of the method for diagnosing bone metabolism disorders in children under one year old in the Kazakh population
The state of bone metabolism was assessed using the quantitative content of calcium, phosphorus, vitamin D, osteocalcin, and parathyroid hormone.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start31 Dec 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone Remodeling DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Kazakhstan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Kim, West Kazakhstan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375331
- Sponsor's protocol ID
- 777.04.12.2020
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bizzaro G, Antico A, Fortunato A, Bizzaro N. Vitamin D and Autoimmune Diseases: Is Vitamin D Receptor (VDR) Polymorphism the Culprit? Isr Med Assoc J. 2017 Jul;19(7):438-443.
PubMed 28786260Bao L, Chen M, Lei Y, Zhou Z, Shen H, Le F. Association between vitamin D receptor BsmI polymorphism and bone mineral density in pediatric patients: A meta-analysis and systematic review of observational studies. Medicine (Baltimore). 2017 Apr;96(17):e6718. doi: 10.1097/MD.0000000000006718.
PubMed 28445285Basit S. Vitamin D in health and disease: a literature review. Br J Biomed Sci. 2013;70(4):161-72. doi: 10.1080/09674845.2013.11669951.
PubMed 24400428Antonucci R, Locci C, Clemente MG, Chicconi E, Antonucci L. Vitamin D deficiency in childhood: old lessons and current challenges. J Pediatr Endocrinol Metab. 2018 Mar 28;31(3):247-260. doi: 10.1515/jpem-2017-0391.
PubMed 29397388
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Genetic Markers of Bone Metabolism in Children Under One Year of Age in the Kazakh Population
- ClinicalTrials.gov ID
- NCT05375331
- Acronym / sponsor ID
- 777.04.12.2020
- Conditions
- Bone Remodeling Disorder, Child Development, Genetic Change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- West Kazakhstan Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study of children under one year of age for molecular genetic testing-VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) with the study of the frequency distribution of alleles and genotypes by polymorphisms, analysis of the relationship of molecular genetic markers with indicators of bone metabolism.
Detailed description
Children under the age of one year of Kazakh nationality born in Aktobe will be examined.
Each child included in the study will have an individual registration card, where information about the health status of the child and the health status of the mother during pregnancy will be filled in.
A biochemical analysis will be determined for the level of calcium, phosphorus, calcitonin, parathyroid hormone, osteocalcin, vitamin D in blood serum and deoxypyridinoline in urine.
Blood will be taken to determine the genetic polymorphism of VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759).
The state of bone tissue remodeling (osteocalcin, vitamin D, Ca, P, calcitonin, deoxypyridinoline) will be revealed The frequencies of allelic variants of the VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) genes in children under the age of one year in the population of Kazakhstan were determined.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Age groups
- Child
- Study population
- In accordance with the goal and objectives of the project, 245 children under the age of one year from the Kazakh population born in Aktobe will be examined. (N*-13500, p=16% n=204 +20%(41)=245 children). *N is the total fertility of children; n is how many children should be taken + 20% losses. total for research you need 245
Key inclusion criteria (1 listed)
- -Children 0 -12 months old
Key exclusion criteria (4 listed)
- Musculoskeletal system diseases;
- Severe chronic somatic diseases;
- Supplementation of vitamin D in a therapeutic dose;
- Lack of consent of the parents or legal representatives to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optimization of the method for diagnosing bone metabolism disorders in children under one year old in the Kazakh population
Time frame: 2 years
The state of bone metabolism was assessed using the quantitative content of calcium, phosphorus, vitamin D, osteocalcin, and parathyroid hormone.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Results publication: PubMed 28786260Bizzaro G, Antico A, Fortunato A, Bizzaro N. Vitamin D and Autoimmune Diseases: Is Vitamin D Receptor (VDR) Polymorphism the Culprit? Isr Med Assoc J. 2017 Jul;19(7):438-443.
- Results publication: PubMed 28445285Bao L, Chen M, Lei Y, Zhou Z, Shen H, Le F. Association between vitamin D receptor BsmI polymorphism and bone mineral density in pediatric patients: A meta-analysis and systematic review of observational studies. Medicine (Baltimore). 2017 Apr;96(17):e6718. doi: 10.1097/MD.0000000000006718.
- Results publication: PubMed 24400428Basit S. Vitamin D in health and disease: a literature review. Br J Biomed Sci. 2013;70(4):161-72. doi: 10.1080/09674845.2013.11669951.
- Results publication: PubMed 29397388Antonucci R, Locci C, Clemente MG, Chicconi E, Antonucci L. Vitamin D deficiency in childhood: old lessons and current challenges. J Pediatr Endocrinol Metab. 2018 Mar 28;31(3):247-260. doi: 10.1515/jpem-2017-0391.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Remodeling Disorder and Child Development, run by West Kazakhstan Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irina Kim (+7015281354, irina.kim.90@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization of the method for diagnosing bone metabolism disorders in children under one year old in the Kazakh population (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05375331, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.